Senior GCP Quality Auditor (Home Based)

ProClinical is announcing a new vacancy has arisen for a Senior GCP Quality Auditor with an international leading biopharmaceutical company. This company, which specialises in developing and commercialising innovative medicines, is advertising this contract position as a home-based role.

The GCP Quality Auditor will conduct and manage auditing activities that serve to monitor compliance of the R&D clinical operations activities with applicable regulatory requirements, company policies, and procedures.

The incumbent must ensure that audits are planned, conducted, followed up, and managed in accordance with GQA and company procedures as part of a Quality Management Systems that allows the company to achieve a high standard of compliance with regulatory guidance.

Job Responsibilities:

• Maintaining the Global Quality audit schedule for audits within scope of GCP role to ensure completion and adherence to the schedule. These include, but are not limited, to GCP system audits, vendors, investigator, and document audits. In addition, participating at Commercial Operations offices and other audits.
• Independently leading, planning, audit conduct, and reporting of routine and non-routine audits in accordance with the approved schedule.
• Delivering audit reports and reviewing CAPA plans in accordance with internal timelines.
• Maintaining the audit database to assist the manager and team with resource planning and KPIs.
• Maintaining responsibility and oversight of audits conducted by contracts (as required), which includes identifying suitable consultants, setting up contracts, and providing training in accordance with company procedures.
• Contributing to the GQA team by conducting peer reviews of audit reports conducted by other team members.
• Managing audit travel and obtaining appropriate travel documentation as required to perform international audits.
• Reviewing and approving CAPA plans in collaboration with R&D review progress and providing ongoing support in all compliance matters.
• Managing requests for non-routine audits and executing as required.
• Cooperating with R&D, advising and supporting the company in devising and executing remediation actions to ensure compliance to regulatory and Global Quality expectations and requirements.
• Contributing to the continuous improvement and maintenance of the GQA and Global QMS by writing SOPs and guiding documents; updating GxP report templates, checklists, and other documents as requested by the GQA director.
• Participating and contributing to the team activities for continuous improvement and maintenance of a global GxP compliance platform for reporting, reviewing, and trending Global Quality Audit KPIs.
• Contributing to team reporting requirements as requirements as required by providing Quality Audit Director with relevant KPI information.
• Collaborating and contributing to the team to design and enhance the quality management system, including the ongoing development of SOPs, tools that support audits, checklists, guides, and reports.
• Programming and enhancing the quality system.
• Completing all training requirements in a timely manner and responsible for ongoing maintenance of personal training records to ensure inspection reading at all times.
• Maintaining current awareness of the regulatory and pharmaceutical industry environment.
• Influencing internal Business Partners and stakeholders on best quality & compliance practices to enhance the company quality mindset.
• Participating in and contributing to team meetings as required by the line manager and other team members.
• Participating in Regulatory Authority inspections as required, providing support at the sponsor, CRO, or trial site.
• Acting as a Subject Matter Expert/Point of Contact to provide expertise and knowledge to R&D Business Partners, company entities, etc., on quality and compliance processes/procedures.
• Enhancing and maintaining a global platform for sharing Regulatory Inspection deficiencies and 'lessons learned' to ensure such information is communicated, tracked, and responded to accordingly by relevant GCP functions.
• Collaborating cross functionally with key stakeholders to maintain agility in the audit.

Skills and Requirements:

• At least a bachelor's degree.
• At least 5 years of experience in conducting GCP audits.
• At least 5 years of experience in Regulatory inspections management.
• Certification as a Lead Auditor.
• Demonstrable in-depth knowledge of GCP requirements and regulations.
• Advanced working knowledge and understanding of the application of GCP, including EMA, FDA regulations, and ICH guidelines required.
• Strong interpersonal skills, including communication, negotiation, and collaboration.
• Experienced with international travel.
• Fluency in spoken and written English.
• Excellent report writing skills.
• A proactive and quality mindset, with the ability to drive change to accomplish strategic objectives.
• A positive attitude and strong work ethic.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Josh Godden on + 442038540101 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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